Microinfuser with automatic needle retraction

ABSTRACT

A device ( 10 ) for delivering a fluid includes a housing ( 12 ) defining an interior space ( 22 ) and having a bottom surface ( 18 ) configured for contacting a patient. The bottom surface ( 18 ) defines a needle opening ( 56 ). The device ( 10 ) also includes a reservoir ( 26 ) disposed within the interior space ( 22 ) of the housing ( 12 ) for containing a fluid therein, a needle carrier ( 30 ) disposed within the housing ( 12 ), and an injection needle ( 28 ) supported by the needle carrier ( 30 ) and defining a lumen. The lumen of the injection needle ( 28 ) is configured to be placed in fluid communication with the reservoir ( 26 ). The injection needle ( 28 ) is transitionable from an initial position in which the injection needle is disposed within the housing ( 12 ), to a use position in which the injection needle extends through the needle opening ( 56 ), and a substantially shielded position in which the injection needle ( 28 ) is disposed within the housing ( 12 ) and the lumen of the needle ( 28 ) is blocked by a portion of the housing ( 12 ).

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates generally to a device for delivering afluid into the body of a patient by injection and, more particularly, toan infusing device with a mechanism for automatically retracting aneedle after injection.

Description of Related Art

Various types of automatic injection devices have been developed toallow drug solutions and other liquid therapeutic preparations to beadministered by untrained personnel or to be self-injected. Generally,these devices include a reservoir that is pre-filled with the liquidtherapeutic preparation, and some type of automatic needle-injectionmechanism (usually of the spring-loaded type) that can be triggered bythe user. When the volume of fluid or drug to be administered isgenerally below a certain volume, such as 1 mL, an auto injector istypically used, which typically has an injection time of about 10 to 15seconds. When the volume of fluid or drug to be administered is above 1mL, the injection time generally becomes longer resulting indifficulties for the patient to maintain contact between the device andthe target area of the patient's skin. Further, as the volume of drug tobe administered becomes larger, increasing the time period for injectionbecomes desirable. The traditional method for a drug to be injectedslowly into a patient is to initiate an IV and inject the drug into thepatient's body slowly. Such a procedure is typically performed in ahospital or outpatient setting.

Certain devices allow for self-injection in a home setting and arecapable of gradually infusing a liquid therapeutic preparation into theskin of a patient. In some cases, these devices are small enough (bothin height and in overall size) to allow them to be “worn” by a patientwhile the liquid therapeutic preparation is being infused into thepatient. These devices typically include a pump or other type ofdischarge mechanism to force the liquid therapeutic preparation to flowout of a reservoir and into the injection or infusion needle. Suchdevices also typically include a valve or flow control mechanism tocause the liquid therapeutic preparation to begin to flow at the propertime and a triggering mechanism to initiate the injection. As withconventional syringes, needle-stick injuries with self-injectioninfusing devices are a concern.

SUMMARY OF THE INVENTION

In one embodiment, a device for delivering a fluid includes a housingdefining an interior space and having a bottom surface configured forcontacting a patient. The bottom surface defines a needle opening. Thedevice also includes a reservoir disposed within the interior space ofthe housing for containing a fluid therein, a needle carrier disposedwithin the housing, and an injection needle supported by the needlecarrier and defining a lumen. The lumen of the injection needle isconfigured to be placed in fluid communication with the reservoir. Theinjection needle is transitionable from an initial position in which theinjection needle is disposed within the housing, to a use position inwhich the injection needle extends through the needle opening, and asubstantially shielded position in which the injection needle isdisposed within the housing and the lumen of the needle is blocked by aportion of the housing.

The device may also include a needle actuator having a first rampportion having an inclined section and a level section with the levelsection being generally parallel to the bottom surface of the housing.The needle carrier may include a first engagement for contacting theinclined section of the first ramp portion to transition the injectionneedle from the initial position to the use position. The needleactuator may also include a second ramp portion having an inclinedsection and a level section being generally parallel to the bottomsurface of the housing and the needle carrier may include a secondengagement for contacting the inclined section of the second rampportion to transition the injection needle from the use position to theshielded position. The device may include a pad disposed within thehousing, where the lumen of the injection needle is blocked by the padwhen the injection needle is in the shielded position. The needleactuator may be configured to drive the injection needle into the padwhen the injection needle is transitioned from the use position to theshielded position. At least a portion of the pad may be received by theneedle actuator in the shielded position.

The reservoir may be configured to automatically supply fluid to theinjection needle after the injection needle is transitioned from theinitial position to the use position. A needle actuator may beconfigured to engage the needle carrier to transition the injectionneedle from the initial position, to the use position, and the shieldedposition. The reservoir may comprise a syringe assembly including asyringe barrel for containing a fluid therein, a stopper disposed withinthe syringe barrel, and a plunger configured to advance the stopperwithin the syringe barrel to expel the fluid therefrom. The device mayinclude a plunger stop engaged with the plunger when the injectionneedle is in the initial position, wherein the plunger stop isconfigured to engage the needle carrier and release the plunger stopfrom the plunger when the injection needle is transitioned from theinitial position to the use position. The device may include a needlestop configured to restrict movement of the injection needle from theuse position to the shielded position until a predetermined amount offluid has been dispensed from the reservoir. The needle stop may includea rotatable body which engages the needle actuator and the plunger whenthe injection needle is in the use position with the needle stopdisengaging from the plunger when the injection needle is transitionedfrom the use position to the shielded position.

The device may also include an activation button, wherein deployment ofthe activation button allows the injection needle to transition from theinitial position to the use position. The device may be provided with anindicator for indicating when the injection needle is in the initialposition, the use position, and the shielded position.

In a further embodiment, a device for delivering a fluid includes ahousing defining an interior space and having a bottom surfaceconfigured for contacting a patient. The bottom surface defines a needleopening. The device further includes a reservoir disposed within theinterior space of the housing for containing a fluid therein, a needlecarrier disposed within the housing, and an injection needle supportedby the needle carrier and defining a lumen. The lumen of the injectionneedle is configured to be placed in fluid communication with thereservoir, wherein the injection needle is transitionable from aninitial position in which the injection needle is disposed within thehousing, to a use position in which the injection needle extends throughthe needle opening, and a substantially shielded position in which theinjection needle is disposed within the housing. The device alsoincludes an indicator for indicating when the injection needle is in theinitial position, the use position, and the shielded position.

The housing may include at least one indicator lens, where the indicatoris visible from an exterior of the housing via the indicator lens. Theindicator may provide a visual and tactile indication of the position ofthe injection needle. The indicator may include an indicator post withthe housing defining an indicator opening. The indicator post isdisposed within the housing when the injection needle is in the initialposition and the use position and extends through the indicator openingwhen the injection needle is in the shielded position.

In another embodiment, a device for delivering a fluid includes ahousing defining an interior space and having a bottom surfaceconfigured for contacting a patient. The bottom surface defines a needleopening. The device further includes a reservoir disposed within theinterior space of the housing for containing a fluid therein, a needlecarrier disposed within the housing, an activation member, and aninjection needle supported by the needle carrier and defining a lumen.The lumen of the injection needle is configured to be placed in fluidcommunication with the reservoir. Deployment of the activation membercauses the injection needle to transition from an initial position inwhich the injection needle is disposed within the housing, to a useposition in which the injection needle extends through the needleopening, and a substantially shielded position in which the injectionneedle is disposed within the housing.

The device may include a needle actuator configured to engage the needlecarrier to transition the injection needle from the initial position, tothe use position, and the shielded position. The device may also includea needle stop configured to restrict movement of the injection needlefrom the use position to the shielded position until a predeterminedamount of fluid has been dispensed from the reservoir. The activationmember may engage the needle actuator when the injection needle is inthe initial position. The needle stop may engage the needle actuatorwhen the injection needle is in the use position, and the needle stopmay be disengaged from the needle actuator when the injection needle isin the shielded position.

Further details and advantages of the invention will become clear uponreading the following detailed description in conjunction with theaccompanying drawing figures, wherein like parts are designated withlike reference numerals throughout.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device for delivering a fluid into apatient by injection in accordance with an embodiment of the presentinvention.

FIG. 2 is a front view of the device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 3 is a right view of the device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 4 is a rear view of the device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 5 is a top view of the device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 6 is a left view of the device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 7 is a bottom view of the device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 8 is a bottom view of the device of FIG. 1 showing a needle capremoved in accordance with an embodiment of the present invention.

FIG. 9 is a perspective view of the device of FIG. 1 showing a top coverremoved in accordance with an embodiment of the present invention.

FIG. 10 is a perspective view of the device of FIG. 1 showing detail ofan activation button in accordance with an embodiment of the presentinvention.

FIG. 11 is a perspective view of an activation button in accordance withan embodiment of the present invention.

FIG. 12 is a bottom view of the device of FIG. 1 showing a bottomportion of the housing removed in accordance with an embodiment of thepresent invention.

FIG. 13 is a perspective view of the device of FIG. 1 showing a firstposition of a plunger stop in accordance with an embodiment of thepresent invention.

FIG. 14 is an enlarged perspective view of the device of FIG. 1 showinga second position of a plunger stop in accordance with an embodiment ofthe present invention.

FIG. 15 is a partial perspective view of the device of FIG. 1 showing asecond position of a plunger stop in accordance with an embodiment ofthe present invention.

FIG. 16 is a cross-sectional view taken along line 16-16 of FIG. 10 inaccordance with an embodiment of the present invention.

FIG. 17 is a perspective view of a stopper in accordance with anembodiment of the present invention.

FIG. 18 is a perspective view of a stopper in accordance with anembodiment of the present invention.

FIG. 19 is a top view of the device of FIG. 1 showing engagement betweena needle stop and needle actuator in accordance with an embodiment ofthe present invention.

FIG. 20 is a partial bottom view of the device of FIG. 1 showingengagement between a needle stop and plunger in accordance with anembodiment of the present invention.

FIG. 21 is a partial perspective view of the device of FIG. 1 showing aneedle actuator removed and a plunger in an extended position inaccordance with an embodiment of the present invention.

FIG. 22 is a partial top view of the device of FIG. 1 showing a rotatedposition of a needle stop in accordance with an embodiment of thepresent invention.

FIG. 23 is a top perspective view of the device of FIG. 1 showing a useposition of an injector needle in accordance with an embodiment of thepresent invention.

FIG. 24 is a bottom perspective view of the device of FIG. 1 showing ause position of an injector needle in accordance with an embodiment ofthe present invention.

FIG. 25 is a perspective view of the device of FIG. 1 showing aninjector needle transitioning from a use position to a shielded positionin accordance with an embodiment of the present invention.

FIG. 26 is a perspective view of the device of FIG. 1 showing aninjector needle in a shielded position in accordance with an embodimentof the present invention.

FIG. 27 is a partial perspective view of the device of FIG. 1 showing aninjector needle in a shielded position with a needle actuator removed inaccordance with an embodiment of the present invention.

FIG. 28 is a bottom view of the device of FIG. 1 showing an injectorneedle in a shielded position in accordance with an embodiment of thepresent invention.

FIG. 29 is a cross-sectional view of a needle actuator in accordancewith an embodiment of the present invention.

FIG. 30 is a schematic view of a needle carrier showing a pre-loadedposition of the needle carrier just prior to movement of an injectionneedle to a use position in accordance with an embodiment of the presentinvention.

FIG. 31 is a schematic view of a needle carrier showing a pre-loadedposition of the needle carrier just prior to movement of an injectionneedle to a shielded position in accordance with an embodiment of thepresent invention.

FIG. 32 is a top view of the device of FIG. 1 showing a needle carrierremoved in accordance with an embodiment of the present invention.

FIG. 33 is a perspective view of a device for delivering a fluid into apatient by injection in accordance with a further embodiment of thepresent invention.

FIG. 34 is a perspective view of the device of FIG. 33 showing buttonlock in a second position in accordance with a further embodiment of thepresent invention.

FIG. 35 is a perspective view of the device of FIG. 33 showing a topcover removed in accordance with a further embodiment of the presentinvention.

FIG. 36 is a perspective view of the device of FIG. 33 showing thedevice at the end of an injection cycle in accordance with a furtherembodiment of the present invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

For purposes of the description hereinafter, spatial orientation terms,if used, shall relate to the referenced embodiment as it is oriented inthe accompanying drawing figures or otherwise described in the followingdetailed description. However, it is to be understood that theembodiments described hereinafter may assume many alternative variationsand embodiments. It is also to be understood that the specific devicesillustrated in the accompanying drawing figures and described herein aresimply exemplary and should not be considered as limiting.

Referring to FIGS. 1-16, a device for delivering a fluid into a patientby injection 10 is shown. The device 10 generally includes a housing 12having a first end 14 and a second end 16. The housing 12 includes abottom portion 18 and a top cover 20 that define an interior space 22.The device further includes a reservoir 26, an injection needle 28, aneedle carrier 30, a needle actuator 32, a plunger stop 34, a needlestop 36, and an activation button 38 that are accommodated by thehousing 12. The device 10 is utilized to inject a drug or medicamentinto a patient and is configured to be engaged with, such as mountedonto, a patient's skin for self-administration. Any form of medicament,e.g., liquid or slurry, including one or more pharmaceutically-activeagents, may be administered by the device 10.

Referring to FIGS. 1-9, the top cover 20 of the housing 12 includes areservoir opening 44, a button opening 46, a first indicator lens 48, asecond indicator lens 50, and third indicator lens 52. The reservoiropening 44 allows for the visual inspection of the reservoir 26 withoutremoving the top cover 20. The button opening 46 receives the activationbutton 38 with a portion of the activation button 38 extending throughthe opening 46. The first, second, and third indicator lenses 48, 50, 52may allow visual inspection of a portion of the needle actuator 32 toprovide an indication of the status of the device 10. In particular, thefirst, second, and third indicator lenses 48, 50, 52 may be made from atransparent material to allow visual inspection of the interior space 22of the housing 12, as will be described herein. The bottom portion 18 ofthe housing 12 has a bottom surface 54 that defines a needle opening 56.The bottom surface 54 is configured to be placed into contact with atarget surface (not shown) of a patient. As shown in FIG. 7, a needlecap 58 is received by the needle opening 56 in an initial pre-useposition to shield the injection needle 28, as shown in FIG. 8, prior touse.

Referring to FIGS. 10-12, the activation button 38 includes a body 60having a top surface 62 for engagement by a user. The top surface 62 ofthe body 60 extends through the button opening 46 of the housing 12. Apair of tab members 64 extends outwardly from the body 60 and isreceived by the top cover 20 of the housing 12. The body 60 of theactivation button 38 includes a lock member 66 extending toward theneedle actuator 32. The activation button 38 is moveable within thehousing 12 and is configured to restrict movement of the needle actuator32. In particular, when the activation button 38 is in the positionshown in FIG. 10, the lock member 66 of the activation button 38 will bein interference engagement with the needle actuator 32 to restrictforward movement of the needle actuator 32. Pressing downward on theactivation button 38 will release the lock member 66 from the needleactuator 32 and start the operation of the device 10, which will bediscussed in more detail below.

Referring to FIGS. 13-15, the plunger stop 34 includes a body 70 havingan attachment portion 72, a plunger engagement portion 74, and anactuator tab 76. The attachment portion 72 is configured to be rotatablysecured to the bottom portion 18 of the housing 12. The plungerengagement portion 74 extends from the attachment portion 72 and isconfigured to engage the reservoir 26 as discussed in more detail below.The actuator tab 76 extends from the attachment portion 72 and includesan inclined planar surface 78 that is configured to engage acorrespondingly shaped portion of the needle actuator 32. The plungerstop 34 has a first position, as shown in FIG. 13, and a secondposition, as shown in FIGS. 14 and 15.

Referring to FIGS. 13 and 16-18, the reservoir 26 is embodied as asyringe assembly 82 having a syringe barrel 84, a valve stopper 86, aplunger 88, and a fill stopper 90, although other suitable reservoirsmay be utilized. The syringe assembly 82 is configured to be disposedwithin the housing 12 and arranged along a longitudinal axis of thehousing 12. The syringe barrel 84 defines an interior space 92 forreceiving a fluid therein and also receives the valve stopper 86 andfill stopper 90. The plunger 88 includes a first end 94 and a second end96 with the second end 96 of the plunger 88 engaged with the valvestopper 86. A valve member 98 is received by the valve stopper 86 and ismoveable between an open position and a closed position. The valvestopper 86 includes a passageway 102 having an inlet 104 and an outlet106 generally extending through the valve stopper 86. The passageway 102of the valve stopper 86 is in fluid communication with the interiorspace 92 of the syringe barrel 84 when the valve member 98 is in theopen position. A tube (not shown) extends from the outlet 106 of thepassageway 102 to the injection needle 28. The syringe assembly 82further includes a plunger spring 108 configured to bias the valvestopper 86 towards the fill stopper 90 such that fluid within thesyringe barrel 84 is displaced through the passageway 102 of the valvestopper 86. A plunger guard 110 is disposed over the plunger spring 108.The first end 94 of the plunger 88 defines a notch 112 configured toengage the plunger engagement portion 74 of the plunger stop 34. Theplunger 88 also includes an elongate arm 114 extending generallyparallel to the syringe barrel 84 and configured to engage the needlestop 36 based on a predetermined position of the plunger 88 relative tothe syringe barrel 84. The plunger 88 is configured to move the valvestopper 86 toward the fill stopper 90 to dispense medicament or fluidfrom the syringe barrel 84.

Referring to FIGS. 6 and 7, the syringe assembly 82 also includes a fillcover 116 that seals and encloses the fill stopper 90. The fill cover116 provides access to the fill stopper 90 during assembly of the device10. The fill cover 116 is configured to be secured to the housing 12without being removable by a user of the device 10.

Referring to FIGS. 19-22, the needle stop 36 includes a body 120 thatdefines a central opening 122 for receiving a pin 124 extending upwardfrom the bottom portion 18 of the housing 12. The body 120 of the needlestop 36 is rotatable about the pin 124 and includes an actuator surface126 and a plunger surface 128. The actuator surface 126 and the plungersurface 128 are configured to engage the needle actuator 32 and theplunger 88, respectively. The plunger surface 128 is raised andpositioned upwardly from the actuator surface 126.

Referring to FIGS. 23-29 and 32, the needle actuator 32 includes anelongate body 132 with a first end 134 and a second end 136. The body132 of the needle actuator 32 includes a pair of sidewalls 138 extendingbetween the first and second ends 134, 136. The body 132 of the actuator32 defines an interior space 140 configured to receive a portion of theneedle carrier 30. First and second ramp portions 142, 144 extend inwardfrom one of the sidewalls 138 toward the interior space 140. The firstramp portion 142 includes a downward inclined section 146 and a levelsection 148. The downward inclined section 146 of the first ramp portion142 extends toward the bottom portion 18 of the housing 12 and towardsthe second end 136 of the needle actuator 32. The level section 148 isgenerally parallel to the bottom surface 54 of the bottom portion 18 ofthe housing 12 and is positioned intermediate the ends 134, 136 of theneedle actuator 32. The second ramp portion 144 includes an upwardinclined section 150 extending away from the bottom portion 18 of thehousing 12 and towards the second end 136 of the needle actuator 32. Thesecond ramp portion 144 also includes a level section 151 that isgenerally parallel to the bottom surface 54 of the bottom portion 18 ofthe housing 12. Each of the sidewalls 138 of the needle actuator 32includes the first and second ramp portions 142, 144, although only oneof the sidewalls 138 may be provided with the ramp portions 142, 144.The needle actuator 32 also includes a plunger engagement tab 152 and anindicator tab 154. The plunger engagement tab 152 includes an inclinedplanar portion 156 that is configured to engage the actuator tab 76 ofthe plunger stop 34. The plunger engagement tab 152 is disposed adjacentto the first end 134 of the body 132 of the needle actuator 32. Theindicator tab 154 includes a planar surface 158 having first and secondindicator colors 160, 162. The indicator tab 154 is disposed towards thefirst end 134 of the body 132 of the needle actuator 32 and is arrangedsubstantially perpendicular to one of the sidewalls 138.

Referring to FIGS. 12, 23-29, and 32, the needle actuator 32 furtherincludes a button engagement 164 extending substantially perpendicularto one of the sidewalls 138 and positioned intermediate the first andsecond ends 134, 136 of the needle actuator 32. The button engagement164 is configured to engage the lock member 66 of the activation button38. Upon downward movement of the activation button 38, the buttonengagement 164 of the needle actuator 32 is configured to be releasedfrom engagement with the lock member 66 of the activation button 38. Asshown in FIG. 12, a bottom 165 of the needle actuator 32 defines abottom opening 166. Further, the needle actuator 32 includes a needlespring 168 disposed within the interior space 140 of the needle actuator32 and is configured to bias the needle actuator 32 forward toward thefirst end 14 of the housing 12. The needle actuator 32 also includes apad 170 disposed within the interior space 140 of the needle actuator 32and positioned on a bottom surface 172 of the needle actuator 32. Thepad 170 is constructed from a rubber material, although other suitablematerials may be utilized. Thus, the needle actuator 32 has a firstposition disposed adjacent to the second end 16 of the housing 12 and asecond position disposed adjacent to the first end 14 of the housing 12with the needle spring 168 configured to move the needle actuator 32from the first position to the second position.

Referring to FIGS. 9, 10, and 12, the needle carrier 30 includes anelongate body 180 having a first end 182 and a second end 184. The body180 of the needle carrier 30 includes an attachment member 186 at thefirst end 182 of the body 180 that is configured to be secured to thebottom portion 18 of the housing 12. The needle carrier 30 is arrangedto be generally cantilevered from the attachment member 186 andextending from the first end 14 of the housing 12 towards the second end16 of the housing 12. A portion of the needle carrier 30 is configuredto be received by and engaged with the needle actuator 32. The needlecarrier 30 also includes a first engagement 188 disposed between theends 182, 184 of the body 180 of the needle carrier 30 and a secondengagement 190 disposed adjacent the second end 184 of the body 180 ofthe needle carrier 30. The first and second engagements 188, 190 extendradially outward from the body 180 and substantially perpendicular to alongitudinal axis of the needle carrier 30. The needle carrier 30further includes a generally cylindrical needle receiver 192 thatreceives and engages the injection needle 28. The needle earner 30defines a passageway 194 having an inlet 196 that is configured toreceive the tubing (not shown) from the outlet 106 of the valve stopper86 of the syringe assembly 82. A lumen (not shown) of the injectionneedle 28 is in fluid communication with the passageway 194 and thetubing from the valve stopper 86. The needle carrier 30 is generallyflexible or semi-rigid to allow the needle carrier 30 to flex from anon-biased state and return to the non-biased state after flexing.

Referring to FIGS. 9-32, upon assembly of the device 10, the device 10will be in an initial, pre-use state. As discussed in more detail below,the device 10 has a pre-use state, a use state, and a completed state.In the initial state, the syringe assembly 82 is received by the bottomportion 18 of the housing 12 and generally extends from the first end 14of the housing 12 to the second end 16 of the housing 12. The medicamentis provided within the syringe barrel 84 and the plunger 88 is in afully retracted position as shown in FIG. 9. The plunger spring 108engages the bottom portion 18 of the housing 12 and the plunger 88 tobias the plunger 88 and valve stopper 86 towards the fill stopper 90.The valve member 98 arranged within the valve stopper 86 is in a closedposition. The attachment portion 72 of the plunger stop 34 is secured tothe bottom portion 18 of the housing 12 and allows the plunger stop 34to rotate relative to the bottom portion 18 of the housing 12. Theplunger engagement portion 74 of the plunger stop 34 engages the notch112 of the plunger 88 to restrict movement of the plunger 88 towards thefill stopper 90. The activation button 38 is in a raised position withthe top surface 62 of the body 60 extending through the button opening46 of the housing 12. The lock member 66 is engaged with the buttonengagement 164 of the needle actuator 32 and prevents movement of theneedle actuator 32. The needle actuator 32 is positioned adjacent to thesecond end 16 of the housing 12 with the second end 136 of the needleactuator 32 abutting the second end 16 of the housing 12. The needlespring 168 is disposed within the interior space 140 of the needleactuator 32 with a first end 200 of the spring 168 engaging the firstend 134 of the needle actuator 32 and a second end 198 of the needlespring 168 engaging a spring seat 202 on the bottom portion 18 of thehousing 12. Thus, the needle actuator 32 is biased by the needle spring168 and configured to move the needle actuator 32 from the second end 16of the housing 12 to the first end 14 of the housing 12 upon release ofthe button engagement 164 with the lock member 66 of the activationbutton 38.

The syringe barrel 84 may be filled with a medicament by any suitablemethod. In one embodiment, with the fill cover 116 and fill stopper 90removed from the housing 12, the syringe barrel 84 is filled withmedicament. A guide tube (not shown), which has a slightly smallerdiameter than the inner diameter of the syringe barrel 84, is used tosqueeze and place the fill stopper 90 just above the medicament beforeretracting and leaving the fill stopper 90 in place. A further methoduses a machine or apparatus to engage the top of the syringe barrel 84and evacuate the syringe barrel 84 to a preset vacuum. When the presetvacuum is reached, the fill stopper 90 is pushed down into the syringebarrel 84 and the vacuum is released which causes atmospheric pressureto draw the fill stopper 90 into place while leaving no air gap. Anothermethod of filling the syringe barrel 84 utilizes a piece of wire orstring along the outside of the fill stopper 90 while the fill stopper90 is positioned within the syringe barrel 84. The wire or stringcreates a temporary break in the seal that allows air to escape frombetween the fill stopper 90 and the medicament as the fill stopper 90 ispushed into place.

In the initial, pre-use state of the device 10, the needle carrier 30has a non-biased position with the elongate body 180 of the needlecarrier 30 being substantially planar. The attachment member 186 of theneedle carrier 30 is rotatably secured to a carrier seat 204 extendingupwardly from the bottom portion 18 of the housing 12. A portion of theneedle carrier 30 is disposed within the needle actuator 32 with theelongate body 180 of the needle carrier 30 extending substantiallyparallel to the needle actuator 32. The first engagement 188 of theneedle carrier 30 is positioned adjacent to the first ramp portion 142of the needle actuator 32. The plunger engagement tab 152 of the needleactuator 32 is positioned adjacent to the actuator tab 76 of the plungerstop 34. Further, the indicator tab 154 of the needle actuator 32 ispositioned such that the first indicator color 160 is visible throughthe first indicator lens 48 of the housing 12 to indicate that thedevice 10 is ready to use.

Referring to FIGS. 14 and 15, after removing the needle cap 58 from theneedle opening 56 in the bottom portion 18 of the housing 12 anddepressing the activation button 38 to move the activation button 38further within the housing 12, the device 10 transitions from thepre-use position to the use position. After pressing the activationbutton 38, the lock member 66 of the activation button 38 is releasedfrom the button engagement 164 of the needle actuator 32 to allowforward movement of the needle actuator 32 towards the first end 14 ofthe housing 12. The needle actuator 32 moves forward, as shown in FIG.14, and the plunger engagement tab 152 of the needle actuator 32 engagesthe actuator tab 76 of the plunger stop 34 thereby causing the plungerstop 34 to rotate downward to the position shown in FIG. 15. After theplunger stop 34 has rotated downward a sufficient distance, the plungerengagement portion 74 of the plunger stop 34 is released from the notch112 of the plunger 88 thereby allowing the plunger 88 to be moved towardthe fill stopper 90 by the plunger spring 108. Upon movement of theplunger 88, the valve member 98 within the valve stopper 86 is moved tothe open position to place the injection needle 28 in fluidcommunication with the syringe barrel 84. In particular, in the pre-useposition, the plunger 88 is moveable within the valve stopper 86 apredetermined distance. When the plunger 88 disengages from the plungerstop 34, the plunger 88 moves within the valve stopper 86 and causes thevalve member 98 to move to the open position. Movement of the valvestopper 86 toward the fill stopper 90 causes fluid within the syringebarrel 84 to move through the passageway 102 in the valve stopper 86through the tubing (not shown) and through the lumen of the injectionneedle 28.

Referring to FIGS. 23 and 24, when the device 10 is transitioned to theuse state from the pre-use state, the injection needle 28 is moved to ause position where the injection needle 28 extends through the needleopening 56 in the bottom portion 18 of the housing 12. In use, thebottom surface 54 of the bottom portion 18 of the housing 12 will bearranged against a target surface of a patient's body such that theinjection needle 28 pierces the target surface of the patient. Asdiscussed above, when the injection needle 28 is moved from the initialposition to the use position, fluid within the syringe barrel 84 isautomatically supplied to the lumen of the injection needle 28 forinfusion into the patient.

Referring to FIGS. 29 and 30, during the transition of the injectionneedle 28 from the initial position to the use position, the needlecarrier 30 is pre-loaded to snap the needle carrier 30 downward toquickly pierce the target area of a patient's body with the injectionneedle 28. In particular, as the needle actuator 32 moves forward towardthe first end 14 of the housing 12, the first engagement 188 of theneedle carrier 30 engages the bottom of the inclined section 146 of thefirst ramp portion 142 while the second engagement 190 of the needlecarrier 30 engages the top of the level section 148 of the first rampportion 142. Further movement of the needle actuator 32 causes theintermediate portion between the first and second ends 182, 184 of theneedle carrier 30 to flex, as shown in FIG. 30, while the second end 184of the needle carrier 30 is supported by the level section 148 of thefirst ramp portion 142. Continued movement of the needle actuator 32causes the second engagement 190 of the needle carrier 30 to extendbeyond the level section 148 of the first ramp portion 142 therebyreleasing the second end 184 of the needle carrier 30 and causing theneedle carrier 30 and injection needle 28 to snap downwardly.

Referring to FIG. 23, when the device 10 is in the use state and theinjection needle 28 is in the use position, the needle carrier 30 ispositioned between the first and second ends 14, 16 of the housing 12.The first indicator color 160 of the indicator tab 154 is positionedbelow the second indicator lens 50 of the housing 12 to indicate thatthe device 10 is in the use state.

Referring to FIGS. 19 and 20, continued movement of the needle actuator32 is restricted when the device 10 is in the use state until apredetermined amount of medicament has been dispensed from the syringebarrel 84. In particular, the actuator surface 126 of the needle stop 36engages the needle actuator 32 and the plunger surface 128 engages theelongate arm 114 of the plunger 88. The needle stop 36 is restrictedfrom rotating when the needle actuator 32 engages the needle stop 36 dueto the interference of the plunger surface 128 of the needle stop 36with the elongate arm 114 of the plunger 88. Upon further movement ofthe plunger 88, such as when the valve stopper 86 engages the fillstopper 90, the plunger surface 128 of the needle stop 36 will be freefrom interference with the elongate arm 114 of the plunger 88 to allowthe needle actuator 32 to rotate the needle stop 36 and continuemovement of the needle actuator 32 toward the first end 14 of thehousing 12.

Referring to FIGS. 21, 22, and 25-28, as the needle actuator 32 is movedpast the needle stop 36 toward the first end 14 of the housing 12, thedevice 10 is transitioned from the use state to the completed state. Asdiscussed above, after the plunger 88 moves the valve stopper 86 intoengagement with the fill stopper 90 after a predetermined amount oftime, the needle stop 36 rotates and allows the needle actuator 32 tomove to the first end 14 of the housing 12 with the first end 134 of theneedle actuator 32 abutting the first end 14 of the housing 12, as shownin FIG. 26. The rotation of the needle stop 36 and the clearing of theelongate arm 114 of the plunger 88 is shown in FIGS. 21 and 22. Theinjection needle 28 is transitioned from the use position to theshielded position where the lumen of the injection needle 28 is blockedand where the injection needle 28 is positioned within the housing 12.In particular, in the shielded position, the injection needle 28 engagesthe pad 170 positioned within the needle actuator 32 to block the lumenof the injection needle 28 and prevent fluid from exiting the injectionneedle 28. In the completed state of the device, the second indicatorcolor 162 of the indicator tab 154 of the needle actuator 32 ispositioned below the third indicator lens 52 of the housing 12 toindicate the completed state of the device 10. Further, as shown in FIG.28, the bottom 165 of the needle actuator 32 closes the needle opening56 in the bottom portion 18 of the housing 12.

Referring to FIGS. 25, 29, and 31, during the transition of theinjection needle 28 from the use position to the shielded position, theneedle carrier 30 is pre-loaded to snap the needle carrier 30 downwardto engage the pad 170 positioned within the needle actuator 32. As theneedle actuator 32 moves forward toward the first end 14 of the housing12, the first engagement 188 of the needle carrier 30 engages the bottomof the level section 148 of the first ramp portion 142 while the secondengagement 190 of the needle carrier 30 engages the top of the inclinedsection 150 of the second ramp portion 144. Further movement of theneedle actuator 32 causes the second end 184 of the needle carrier 30 toflex upwardly as the second engagement 190 proceeds along the inclinedsection 150 of the second ramp portion 144 while the first engagement188 slides along the level section 148 of the first ramp portion 142.Continued movement of the needle actuator 32 towards the first end 14 ofthe housing 12 causes the second engagement 190 of the needle carrier 30to extend beyond the level section 151 of the second ramp portion 144thereby causing the needle carrier 30 and injection needle 28 to snapdownwardly into the pad 170. After the injection needle 28 engages thepad 170, the lumen of the injection needle 28 is blocked by the pad 170to prevent fluid from leaking out of the device 10 when the device 10 isin the completed state.

Referring to FIGS. 33-36, a second embodiment of a device 220 fordelivering a fluid into a patient by injection is shown. The device 220is similar to the device 10 shown in FIGS. 1-32, expect for thedifferences discussed below. Like reference numbers are used for likeelements. Instead of providing the first, second, and third indicatorlenses 48, 50, 52, the device 220 shown in FIGS. 33-36 includes anindicator lens 222 that extends outward from the top cover 20 of thehousing 12. Further, the needle actuator 32 includes a raised indicatortab 224 that extends upwardly from the body 132 of the needle actuator32. The raised indicator tab 224 of the needle actuator 32 extends intothe indicator lens 222 and is received by the indicator lens 222. Theneedle actuator 32 also includes an indicator post 226 that extendsoutward from the first end 134 of the needle actuator 32. The first end14 of the housing 12 defines an indicator opening 228 configured toreceive the indicator post 226. As the device 220 is moved from thepre-use state, the use state, and the completed state, the indicator tab224 on the needle actuator 32 will move within the indicator lens 222 toprovide an indication of the state of the device 220. Further, when thedevice 220 is in the completed state, the indicator post 226 of theneedle actuator 32 will protrude through the indicator opening 228 ofthe housing 12 to provide visual and tactile feedback of the completedstate of the device 220. The indicator tab 224 and the indicator lens222 arrangement of the present embodiment allows the indicator tab 224to be viewed from a larger viewing area compared to the indicatorarrangement of the first embodiment.

Referring again to FIGS. 33-36, the device 220 of the second embodimentalso includes a two piece activation button 230 having a first portion232 and a second portion 234. The first portion 232 is moveable relativeto the second portion 234 and has a locked position (shown in FIG. 34)and a use position (shown in FIG. 33). When the first portion 232 is inthe locked position, a protrusion 236 extends radially outward tointerfere with the button opening 46 in the top cover 20 of the housing12 to prevent the activation button 38 from being depressed. When thefirst portion 232 of the activation button 230 is moved to the useposition, the protrusion 236 is received by the second portion 234 andallows the activation button 230 to be depressed to begin the injectionprocess. The activation button 230, however, otherwise operates in asimilar manner as described above in connection with the firstembodiment. Accordingly, the two-piece activation button 230 allows theactivation button to be locked to prevent accidental operation of thedevice.

While several embodiments were described in the foregoing detaileddescription, those skilled in the art may make modifications andalterations to these embodiments without departing from the scope andspirit of the invention. Accordingly, the foregoing description isintended to be illustrative rather than restrictive. The inventiondescribed hereinabove is defined by the appended claims and all changesto the invention that fall within the meaning and the range ofequivalency of the claims are embraced within their scope.

What is claimed is:
 1. A device for delivering a fluid comprising: ahousing defining an interior space and having a bottom surfaceconfigured for contacting a patient, the bottom surface defining aneedle opening; a reservoir disposed within the interior space of thehousing for containing a fluid therein; a needle carrier disposed withinthe housing; a pad disposed within the housing; an injection needlesupported by the needle carrier and defining a lumen in fluidcommunication with the reservoir; a needle actuator; and a needle stopconfigured to restrict movement of the injection needle from the useposition to the shielded position until a predetermined amount of fluidhas been dispensed from the reservoir; wherein the injection needle istransitionable from an initial position in which the injection needle isdisposed within the housing, to a use position in which the injectionneedle extends through the needle opening, and subsequently to asubstantially shielded position in which the injection needle isdisposed within the housing and the lumen of the needle is blocked bythe pad; wherein the needle actuator is configured to drive theinjection needle into the pad when the injection needle is transitionedfrom the use position to the shielded position; wherein the reservoircomprises a syringe assembly, the syringe assembly comprising: a syringebarrel for containing the fluid therein; a stopper disposed within thesyringe barrel; and a plunger configured to advance the stopper withinthe syringe barrel to expel the fluid therefrom; and wherein the needlestop comprises a rotatable body which engages the needle actuator andthe plunger when the injection needle is in the use position, the needlestop disengaging from the plunger when the injection needle istransitioned from the use position to the shielded position.
 2. A devicefor delivering a fluid comprising: a housing defining an interior spaceand having a bottom surface configured for contacting a patient, thebottom surface defining a needle opening; a reservoir disposed withinthe interior space of the housing for containing a fluid therein; aneedle carrier disposed within the housing; a pad disposed within thehousing; an injection needle supported by the needle carrier anddefining a lumen in fluid communication with the reservoir; and a needleactuator; wherein the injection needle is transitionable from an initialposition in which the injection needle is disposed within the housing,to a use position in which the injection needle extends through theneedle opening, and subsequently to a substantially shielded position inwhich the injection needle is disposed within the housing and the lumenof the needle is blocked by the pad; and wherein the needle actuator isconfigured to drive the injection needle into initial contact with thepad when the injection needle is transitioned from the use position tothe shielded position.
 3. The device of claim 1, wherein at least aportion of the pad is received by the needle actuator in the shieldedposition.
 4. The device of claim 1, wherein the reservoir is configuredto automatically supply fluid to the injection needle after theinjection needle is transitioned from the initial position to the useposition.
 5. The device of claim 1, further comprising an activationbutton, wherein deployment of the activation button allows the injectionneedle to transition from the initial position to the use position. 6.The device of claim 1, wherein the pad is disposed on and travels withthe needle actuator.
 7. The device of claim 1, wherein the needleactuator has a first ramp portion having an inclined section and a levelsection, the level section being generally parallel to the bottomsurface of the housing; and wherein the needle carrier comprises a firstengagement for contacting the inclined section of the first ramp portionto transition the injection needle from the initial position to the useposition.
 8. The device of claim 7, wherein the needle actuator furthercomprises a second ramp portion having an inclined section and a levelsection being generally parallel to the bottom surface of the housing,and wherein the needle carrier further comprises a second engagement forcontacting the inclined section of the second ramp portion to transitionthe injection needle from the use position to the shielded position. 9.The device of claim 1, further comprising an indicator for indicatingwhen the injection needle is in the initial position, the use position,and the shielded position.
 10. The device of claim 9, wherein theindicator is disposed on and travels with the needle actuator.
 11. Thedevice of claim 1, wherein the needle actuator is configured to engagethe needle carrier to transition the injection needle from the initialposition, to the use position, and the shielded position.
 12. The deviceof claim 11, wherein the reservoir comprises a syringe assembly, thesyringe assembly comprising: a syringe barrel for containing the fluidtherein; a stopper disposed within the syringe barrel; and a plungerconfigured to advance the stopper within the syringe barrel to expel thefluid therefrom.
 13. The device of claim 12, further comprising aplunger stop engaged with the plunger when the injection needle is inthe initial position, wherein the plunger stop is configured to engagethe needle carrier and release the plunger stop from the plunger whenthe injection needle is transitioned from the initial position to theuse position.
 14. The device of claim 12, further comprising a needlestop configured to restrict movement of the injection needle from theuse position to the shielded position until a predetermined amount offluid has been dispensed from the reservoir.
 15. A device for deliveringa fluid comprising: a housing defining an interior space and having abottom surface configured for contacting a patient, the bottom surfacedefining a needle opening; a reservoir disposed within the interiorspace of the housing for containing a fluid therein; a needle carrierdisposed within the housing; a pad disposed within the housing; a needleactuator; an injection needle supported by the needle carrier anddefining a lumen, the lumen of the injection needle being configured tobe placed in fluid communication with the reservoir, wherein theinjection needle is transitionable from an initial position in which theinjection needle is disposed within the housing, to a use position inwhich the injection needle extends through the needle opening, andsubsequently to a substantially shielded position in which the injectionneedle is disposed within the housing; and an indicator for indicatingwhen the injection needle is in the initial position, the use position,and the shielded position; wherein the needle actuator is configured todrive the injection needle toward the bottom surface and into the padwhen the injection needle is transitioned from the use position to theshielded position.
 16. The device of claim 15, wherein the housingincludes at least one indicator lens, and wherein the indicator isvisible from an exterior of the housing via the indicator lens.
 17. Thedevice of claim 15, wherein the indicator provides a visual and tactileindication of the position of the injection needle.
 18. The device ofclaim 17, wherein the indicator comprises an indicator post and thehousing defines an indicator opening, the indicator post disposed withinthe housing when the injection needle is in the initial position and theuse position, the indicator post extending through the indicator openingwhen the injection needle is in the shielded position.
 19. A device fordelivering a fluid comprising: a housing defining an interior space andhaving a bottom surface configured for contacting a patient, the bottomsurface defining a needle opening; a reservoir disposed within theinterior space of the housing for containing a fluid therein; a needlecarrier disposed within the housing; a pad disposed within the housing;a needle actuator; an activation member; and an injection needlesupported by the needle carrier and defining a lumen, the lumen of theinjection needle configured to be placed in fluid communication with thereservoir; wherein deployment of the activation member causes theinjection needle to transition from an initial position in which theinjection needle is disposed within the housing, to a use position inwhich the injection needle extends through the needle opening, andsubsequently to a substantially shielded position in which the injectionneedle is disposed within the housing; and wherein the needle actuatoris configured to withdraw the injection needle from the use position andsubsequently drive the injection needle into the pad when the injectionneedle is transitioned from the use position to the shielded position.20. The device of claim 19, wherein the needle actuator is configured toengage the needle carrier to transition the injection needle from theinitial position, to the use position, and the shielded position. 21.The device of claim 20, further comprising a needle stop configured torestrict movement of the injection needle from the use position to theshielded position until a predetermined amount of fluid has beendispensed from the reservoir.
 22. The device of claim 21, wherein theactivation member engages the needle actuator when the injection needleis in the initial position, the needle stop engages the needle actuatorwhen the injection needle is in the use position, and the needle stop isdisengaged from the needle actuator when the injection needle is in theshielded position.